Fastener cartridge assembly comprising a cam and driver arrangement

ABSTRACT

A staple cartridge configured to be contained within a channel of a stapling device that has a sled that is selectively actuatable and an anvil portion that is selectively movable between open and closed positions to produce a different opening between the anvil portion and the staple cartridge in the open and closed positions is disclosed. The staple cartridge comprises a plurality of staples, a cartridge body, a first staple driver defining more than one staple forming distance defining at least one first formed staple height, and a second staple driver defining more than one staple forming distance. At least one of the staple forming distances of the second staple driver is different than any of the staple forming distances of the first staple driver and defines at least one second formed staple height which is different than the at least one first formed staple height.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application claiming priority under35 U.S.C. § 120 to U.S. patent application Ser. No. 13/971,012, entitledFASTENER CARTRIDGE ASSEMBLY COMPRISING A CAM AND DRIVER ARRANGEMENT,filed Aug. 20, 2013, which issued on Oct. 24, 2017 as U.S. Pat. No.9,795,382, which is a continuation application claiming priority under35 U.S.C. § 120 to U.S. patent application Ser. No. 13/020,263, filedFeb. 3, 2011, entitled SURGICAL STAPLING SYSTEMS THAT PRODUCE FORMEDSTAPLES HAVING DIFFERENT LENGTHS, which issued on Jan. 28, 2014 as U.S.Pat. No. 8,636,187, which is a continuation application claimingpriority under 35 U.S.C. § 120 to U.S. patent application Ser. No.11/711,979, filed Feb. 28, 2007, entitled SURGICAL STAPLING DEVICES THATPRODUCE FORMED STAPLES HAVING DIFFERENT LENGTHS, which issued on Nov.27, 2012 as U.S. Pat. No. 8,317,070, which is a continuation-in-partpatent application claiming priority under 35 U.S.C. § 120 to U.S.patent application Ser. No. 11/216,562, filed Aug. 31, 2005, entitledSTAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMED STAPLEHEIGHTS, which issued on Mar. 2, 2010 as U.S. Pat. No. 7,669,746, theentire disclosures of which are hereby incorporated by reference herein.

The present application is also related to the following, U.S. patentapplications, which are incorporated herein by reference:

-   -   (1) SURGICAL STAPLING DEVICE WITH STAPLE DRIVER THAT SUPPORTS        MULTIPLE WIRE DIAMETER STAPLES, U.S. patent application Ser. No.        11/711,977, now U.S. Pat. No. 7,673,781;    -   (2) SURGICAL STAPLING DEVICE WITH ANVIL HAVING STAPLE FORMING        POCKETS OF VARYING DEPTH, U.S. patent application Ser. No.        11/714,049, now U.S. Patent Publication No. 2007/0194082;    -   (3) SURGICAL STAPLING DEVICE WITH MULTIPLE STACKED ACTUATOR        WEDGE CAMS FOR DRIVING STAPLE DRIVERS, U.S. patent application        Ser. No. 11/712,315, now U.S. Pat. No. 7,500,979;    -   (4) SURGICAL STAPLING DEVICE WITH STAPLE DRIVERS OF DIFFERENT        HEIGHT, U.S. patent application Ser. No. 11/711,975, now U.S.        Patent Publication No. 2007/0194079; and    -   (5) STAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING        FORMED STAPLE HEIGHTS, U.S. patent application Ser. No.        12/695,359, now U.S. Pat. No. 8,464,923.

FIELD OF THE INVENTION

The present invention relates in general to stapling instruments thatare capable of applying lines of staples and, more particularly, toimprovements relating to staple cartridges for use with surgicalstapling instruments that are capable of applying lines of stapleshaving differing formed staple heights to tissue while simultaneouslycutting the tissue.

BACKGROUND OF THE INVENTION

Surgical staplers have been used in the prior art to simultaneously makea longitudinal incision in tissue and apply lines of staples on opposingsides of the incision. Such instruments commonly include a pair ofcooperating jaw members that, if the instrument is intended forendoscopic or laparoscopic applications, are capable of passing througha cannula passageway. One of the jaw members receives a staple cartridgehaving at least two laterally spaced rows of staples. The other jawmember defines an anvil having staple-forming pockets aligned with therows of staples in the cartridge. The instrument includes a plurality ofreciprocating wedges that, when driven distally, pass through openingsin the staple cartridge and engage drivers supporting the staples toeffect the firing of the staples toward the anvil.

An example of a surgical stapler suitable for endoscopic applications isdescribed in U.S. Pat. No. 7,000,818, the disclosure of which is hereinincorporated by reference in its entirety. In use, a clinician is ableto close the jaw members of the stapler upon tissue to position thetissue prior to firing. Once the clinician has determined that the jawmembers are properly gripping tissue, the clinician can then fire thesurgical stapler, thereby severing and stapling the tissue. Thesimultaneous severing and stapling avoids complications that may arisewhen performing such actions sequentially with different surgical toolsthat respectively only sever or staple.

Whenever a transsection of tissue is across an area of varied tissuecomposition, it would be advantageous for the staples that are closestto the cut line to have one formed height that is less than the formedheight of those staples that are farthest from the cut line. Inpractice, the rows of inside staples serve to provide a hemostaticbarrier, while the outside rows of staples with larger formed heightsprovide a cinching effect where the tissue transitions from the tightlycompressed hemostatic section to the non-compressed adjacent section. Inother applications, it may be useful for the staples in a single line ofstaples to have differing formed heights. U.S. Pat. Nos. 4,941,623 and5,027,834 disclose surgical stapler and cartridge arrangements thatemploy staples that have different prong lengths to ultimately achievelines of staples that have differing formed heights. Likewise, WO2003/094747 discloses a surgical stapler and cartridge that has six rowsof staples wherein the outer two rows of staples comprise staples thatare larger than the staples employed in the inner two rows and middlerows of staples. Thus, all of these approaches require the use ofdifferent sizes of staples in the same cartridge.

BRIEF SUMMARY OF THE INVENTION

In one general aspect, the present invention is directed to surgicalstapling devices that are capable of producing staples of differentformed lengths. For example, in such a device that also cuts the tissuebeing stapled, the inside rows of staples closest to the longitudinalincision line could have a formed height that is less than the formedheight of the outer rows of staples. That way, the inside rows ofstaples may provide a hemostatic barrier, while the outside rows ofstaples with larger formed heights may provide a cinching effect wherethe tissue transitions from the tightly compressed hemostatic section tothe non-compressed adjacent section.

According to various implementations, the staple cartridge may havestaple drivers of different heights to product staples having differentformed lengths. The staples driven by the shorter staple drivers wouldhave longer formed lengths (assuming no other differences that wouldaffect the formed heights of the staples). Also, the staple formingpockets in the anvil may have different depths. Staples formed in deeperpockets would tend to be longer than staples formed in shallow pockets.In addition, some of the staple forming pockets may be formed incompliant material portions of the anvil. Staples formed in such pocketswould tend to be longer than staples formed in a non-compliant (or lesscompliant) portion of the anvil. Additionally, the channel may haveinternal steps that would produce staples having different formedheights. Staples formed with staple drivers starting at a lower stepwould have a longer formed length that stapled formed with stapledrivers starting at a higher step. Also, staples with different wirediameters may be used. Thicker staples would tend to produce stapleswith longer formed lengths. In that connection, embodiments of thepresent invention are directed to staple pushers that can accommodatestaples of varying wire thicknesses. Also, staples of differingmaterials could be used. Staples made of stronger, less compliantmaterials, would tend to produce longer formed staples.

According to other embodiments, the surgical stapling device maycomprise a plurality of stacked wedge band sets. Each stacked wedge bandset may comprise a number of wedge bands stacked one on another. Thewedge bands may be actuated in succession in order to drive the staplesin successive stages. That is, for example, in an embodiment havingthree wedge bands in a stack, the first wedge band may be actuated firstto partially deploy the staples, the second wedge band in stack may beactuated next to begin to form the staples, and the third wedge band inthe stack may be actuated last to finish the formation of the staples.To produce staples having different formed heights, the heights of thestacks (corresponding to the cumulative height of the wedge bands in thestacks) may be different, for example.

In various embodiments, a staple cartridge configured to be containedwithin a channel of a stapling device that has a sled that isselectively actuatable in an axial direction and an anvil portion thatis selectively movable between open and closed positions to produce adifferent opening between the anvil portion and the staple cartridge inthe open and closed positions is disclosed. The staple cartridgecomprises a plurality of staples, a cartridge body supportable withinthe stapling device for selective confronting relationship with theanvil portion thereof when in a closed position, a first staple driver,and a second staple driver. The first staple driver is movably supportedwithin the cartridge body for contact by the sled such that, as the sledis axially advanced through the cartridge body, the first staple driveris configured to be driven in a direction toward the anvil portion whenthe anvil portion is in the closed position. The first staple driverdefines more than one staple forming distance defining at least onefirst formed staple height. The second staple driver is movablysupported within the cartridge body for contact by the sled such that,as the sled is advanced through the cartridge body, the second stapledriver is configured to be driven in the direction toward the anvilportion when the anvil portion is in the closed position. The secondstaple driver defines more than one staple forming distance. At leastone of the staple forming distances of the second staple driver isdifferent than any of the staple forming distances of the first stapledriver and defines at least one second formed staple height which isdifferent than the at least one first formed staple height.

In various embodiments, a stapling assembly comprising an elongate shaftand an end effector extending from the elongate shaft is disclosed. Theend effector is responsive to a closing motion transmitted through theelongate shaft to transition the end effector toward a closedconfiguration. The end effector comprises a sled, an anvil portion, achannel, and a staple cartridge. The staple cartridge comprises aplurality of staples, a cartridge body supported within the channel fora confronting relationship with the anvil portion in the closedconfiguration, a first staple driver, and a second staple driver. Thefirst staple driver is movably supported within the cartridge body forcontact by the sled such that, as the sled is axially advanced throughthe cartridge body, the first staple driver is configured to be drivenin a direction toward the anvil portion when the anvil portion is in theclosed configuration. The first staple driver defines more than onestaple forming distance defining at least one first formed stapleheight. The second staple driver is movably supported within thecartridge body for contact by the sled such that, as the sled isadvanced through the cartridge body, the second staple driver isconfigured to be driven in the direction toward the anvil portion whenthe anvil portion is in the closed configuration. The second stapledriver defines more than one staple forming distance. At least one ofthe staple forming distances of the second staple driver is differentthan the staple forming distances of the first staple driver and definesat least one second formed staple height which is different than the atleast one first formed staple height.

In various embodiments, a stapling assembly comprising an elongate shaftand an end effector extending from the elongate shaft is disclosed. Theend effector is responsive to a closing motion transmitted through theelongate shaft to transition the end effector toward a closedconfiguration. The end effector comprises an anvil portion and a staplecartridge. The staple cartridge comprises a plurality of staples, acartridge body supportable within the end effector for an opposingrelationship with the anvil portion in the closed configuration, a firststaple driver, and a second staple driver. The first staple driver ismovably supported within the cartridge body. The first staple driver isconfigured to be driven in a direction toward the anvil portion when theend effector is in the closed configuration. The first staple driverdefines more than one staple forming distance defining at least onefirst formed staple height. The second staple driver is movablysupported within the cartridge body. The second staple driver isconfigured to be driven in the direction toward the anvil portion whenthe end effector is in the closed configuration. The second stapledriver defines more than one staple forming distance. At least one ofthe staple forming distances of the second staple driver is differentthan the staple forming distances of the first staple driver and definesat least one second formed staple height which is different than the atleast one first formed staple height.

The techniques used to create formed staples of different heights couldbe used in a variety of different surgical stapling devices. Forexample, the stapling devices could be devices that cut the clampedtissue or devices that include no cutting instrument. The surgicalstaplers may be, for example, endocutters, open linear stapler devices,or circular staplers.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate by way of example embodiments ofthe invention, and, together with the general description of theinvention given above, and the detailed description of the embodimentsgiven below, serve to explain the principles of the present invention,wherein:

FIG. 1 depicts a partially cut away side elevation view of a surgicalstapling and severing instrument in an open position according tovarious embodiments of the present invention;

FIG. 2 depicts a cross-sectional side elevation detail view along theline 2-2 of FIG. 1 of an end effector of the surgical stapling andsevering instrument according to various embodiments of the presentinvention;

FIG. 3 depicts an enlarged side elevation view of the firing bar of thesurgical stapling and severing instrument of FIG. 2 according to variousembodiments of the present invention;

FIG. 4 depicts an enlarged front view of the firing bar of the surgicalstapling and severing instrument of FIG. 2 according to variousembodiments of the present invention;

FIG. 5 depicts a cross-sectional side elevation detail view of analternative end effector for the surgical stapling and severinginstrument of FIG. 1, incorporating a firing bar that lacks a middle pinfor preventing pinching of the end effector, according to variousembodiments of the present invention;

FIG. 6 depicts a side elevational view of a handle portion of a proximalend of the surgical stapling and severing instrument of FIG. 1 with aleft side removed to expose interior parts in an unclamped, unfired(“start”) position according to various embodiments of the presentinvention;

FIG. 7 depicts a perspective, exploded view of the handle portion of theproximal end of the surgical stapling and severing instrument of FIG. 1according to various embodiments of the present invention;

FIG. 8 depicts a side elevational view of the handle portion of theproximal end of the surgical stapling and severing instrument of FIG. 1with the left side removed to expose interior parts in the closed(“clamped”) position according to various embodiments of the presentinvention;

FIG. 9 depicts a side elevational view of the handle portion of proximalend of surgical stapling and severing instrument of FIG. 1 with the leftside removed to expose interior parts in the stapled and severed(“fired”) position according to various embodiments of the presentinvention;

FIG. 10 depicts a plan view of a staple cartridge installed in an endeffector according to various embodiments of the present invention;

FIG. 11 is an enlarged plan view of a portion of a staple cartridgeaccording to various embodiments of the present invention;

FIG. 12 is a side view of a staple that may be employed with variousembodiments of the present invention;

FIG. 13 is a front elevational view of one inside double driversupporting two staples thereon according to various embodiments of thepresent invention;

FIG. 14 is a top view of the inside double driver and staples of FIG. 13according to various embodiments of the present invention;

FIG. 14A is an elevational view of the inside double driver of FIG. 13within a portion of a staple cartridge mounted in the end effector andalso illustrating a corresponding portion of the anvil when in a closedposition according to various embodiments of the present invention;

FIG. 15 is a right side elevational view of the inside double driver andstaples of FIGS. 13 and 14 according to various embodiments of thepresent invention;

FIG. 15A is another side elevational view of the inside double driver ofFIG. 15 wherein corresponding portions of the cartridge tray and anvilare illustrated in broken lines to depict the relationships therebetweenaccording to various embodiments of the present invention;

FIG. 16 is a front elevational view of one outside single driversupporting a staple thereon according to various embodiments of thepresent invention;

FIG. 16A is another front view of the outside single driver of FIG. 16with portions of the cartridge tray and anvil shown to illustrate therelationships therebetween according to various embodiments of thepresent invention;

FIG. 17 is a top view of the outside single driver and staple of FIG. 16according to various embodiments of the present invention;

FIG. 18 is an isometric exploded view of the implement portion of thesurgical stapling and severing instrument of FIG. 1 according to variousembodiments of the present invention;

FIG. 19 is a section view taken along line 19-19 of FIG. 10 showing thecross-sectional relationship between the firing bar, elongate channel,wedge sled, staple drivers, staples and staple cartridge according tovarious embodiments of the present invention;

FIG. 19A is another cross-sectional view of an end effector showing thecross-sectional relationship between the firing bar, elongate channel,wedge sled, staple drivers, staples, staple cartridge and anvilaccording to various embodiments of the present invention;

FIG. 20 is a perspective view of one wedge sled according to variousembodiments of the present invention;

FIG. 21 is a side elevational view of an inside sled cam of the wedgesled depicted in FIG. 20 according to various embodiments of the presentinvention;

FIG. 22 is a side elevational view of an outside sled cam of the wedgesled depicted in FIG. 20 according to various embodiments of the presentinvention;

FIG. 23 is an isometric view of the end effector at the distal end ofthe surgical stapling and severing instrument of FIG. 1 with the anvilin the up or open position with the cartridge largely removed exposing asingle staple driver and a double staple driver as exemplary and thewedge sled in its start position against a middle pin of the firing baraccording to various embodiments of the present invention;

FIG. 24 is an isometric view of the end effector at the distal end ofthe surgical stapling and severing instrument of FIG. 1 with the anvilin the up or open position exposing the staple cartridge and cuttingedge of the firing bar according to various embodiments of the presentinvention;

FIG. 25 is an isometric view of the distal end of the surgical staplingand severing instrument of FIG. 1 with the anvil in the up or openposition with the staple cartridge completely removed and a portion ofan elongate channel removed to expose a lowermost pin of the firing baraccording to various embodiments of the present invention;

FIG. 26 is a side elevation view in section showing a mechanicalrelationship between the anvil, elongate channel, and staple cartridgein the closed position of the surgical stapling and severing instrumentof FIG. 1, the section generally taken along lines 26-26 of FIG. 24 toexpose wedge sled, staple drivers and staples but also depicting thefiring bar along the longitudinal centerline according to variousembodiments of the present invention;

FIG. 27 is a cross-sectional view of a portion of a staple cartridgewherein an outside cam of a wedge is adjacent to an outside singledriver according to various embodiments of the present invention;

FIG. 28 is a cross-sectional view of a portion of a staple cartridgewherein an outside cam of a wedge sled is engaging three outside singledrivers according to various embodiments of the present invention;

FIG. 29 is a diagrammatic representation of lines of staples installedon each side of a cut line using a surgical stapling and severinginstrument according to various embodiments of the present invention;

FIG. 30 depicts a staple formed by one inside driver according tovarious embodiments of the present invention;

FIG. 31 depicts another staple formed by one outside driver according tovarious embodiments of the present invention;

FIG. 32 is a diagrammatic representation of lines of staples installedon each side of a cut line using a surgical stapling and severinginstrument according to various embodiments of the present invention;

FIG. 33 is a diagrammatic representation of lines of staples installedon each side of a cut line using a surgical stapling and severinginstrument according to various embodiments of the present invention;

FIG. 34 is a diagrammatic representation of lines of staples installedon each side of a cut line using a surgical stapling and severinginstrument according to various embodiments of the present invention;

FIG. 35 is a side elevation section view of the surgical stapling andsevering instrument of FIG. 1 taken along the longitudinal centerline ofthe end effector in a partially closed but unclamped position grippingtissue according to various embodiments of the present invention;

FIG. 36 depicts a partially cut away side elevational view of thesurgical stapling and severing instrument of FIG. 1 in the closed orclamped position according to various embodiments of the presentinvention;

FIG. 37 depicts a side elevation view of the surgical stapling andsevering instrument of FIG. 1 in the closed or clamped position withtissue properly compressed according to various embodiments of thepresent invention;

FIG. 38 depicts a view in centerline section of the distal end of thesurgical stapling and severing instrument of FIG. 1 in a partially firedposition according to various embodiments of the present invention;

FIG. 39 depicts a partially cut away side elevation view of the surgicalstapling and severing instrument of FIG. 1 in a partially fired positionaccording to various embodiments of the present invention;

FIG. 40 depicts a view in centerline section of the distal end of thesurgical stapling and severing instrument of FIG. 1 in a fully firedposition according to various embodiments of the present invention;

FIG. 41 is a partially cut-away side elevational view of the surgicalstapling and severing instrument of FIG. 1 in a full fired positionaccording to various embodiments of the present invention;

FIGS. 42-44 depict aspects of an end effector having a sled withmultiple sled cams where one sled cam is taller than another accordingto various embodiments of the present invention;

FIG. 45 depicts aspects of an end effector with staple forming pocketshaving varying depths according to various embodiments of the presentinvention;

FIGS. 46-47 depict a double staple driver having staples of differentpre-formation lengths according to various embodiments of the presentinvention;

FIG. 48 depicts a side-view of an end effector having a double stapledriver having different staple driver heights according to variousembodiments of the present invention;

FIGS. 49-50 depict a side-view of an end effector having staple formingpockets of varying depths according to various embodiments of thepresent invention;

FIGS. 51-62 depict aspects of a surgical stapling device having stacksof actuatable wedge bands according to various embodiments of thepresent invention;

FIGS. 63-69 depict aspects of an open linear surgical stapling deviceaccording to various embodiments of the present invention;

FIGS. 70-77 depict cross-sectional front views of an end effectoraccording to various embodiments of the present invention;

FIGS. 78-83 depict staple drivers that can accommodate staple havingdifferent wire diameters according to various embodiments of the presentinvention;

FIGS. 84-89 depict a circular surgical stapling device according tovarious embodiments of the present invention; and

FIGS. 90-95 depict another surgical stapling device according toembodiments of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Turning to the figures, wherein like numerals denote like componentsthroughout the several views, FIGS. 1 and 2 depict one embodiment of asurgical stapling and severing instrument 10 that is capable ofpracticing the unique benefits of the present invention. It should berecognized, however, that the unique and novel aspects of the presentinvention may be advantageously employed in connection with a variety ofother staplers and stapler instruments without departing from the spiritand scope of the present invention. Accordingly, the scope of protectionafforded to the various embodiments of the present invention should notbe limited to use only with the specific type of surgical stapling andsevering instruments described herein.

As can be seen in FIGS. 1 and 2, the surgical stapling and severinginstrument 10 incorporates an end effector 12 having an actuator orE-beam firing mechanism (“firing bar”) 14 that advantageously controlsthe spacing of the end effector 12. In particular, an elongate channel16 and a pivotally translatable anvil 18 are maintained at a spacingthat assures effective stapling and severing. The problems are avoidedassociated with varying amounts of tissue being captured in the endeffector 12.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician gripping a handle of an instrument.Thus, the end effector 12 is distal with respect to the more proximalhandle portion 20. It will be further appreciated that for convenienceand clarity, spatial terms such as “vertical” and “horizontal” are usedherein with respect to the drawings. However, surgical instruments areused in many orientations and positions, and these terms are notintended to be limiting and absolute.

The surgical and stapling and severing instrument 10 includes a handleportion 20 that is connected to an implement portion 22, the latterfurther comprising a shaft 23 distally terminating in the end effector12. The handle portion 20 includes a pistol grip 24 toward which aclosure trigger 26 is pivotally drawn by the clinician to causeclamping, or closing, of the anvil 18 toward the elongate channel 16 ofthe end effector 12. A firing trigger 28 is farther outboard of theclosure trigger 26 and is pivotally drawn by the clinician to cause thestapling and severing of clamped tissue in the end effector 12.

In practice, closure trigger 26 is actuated first. Once the clinician issatisfied with the positioning of the end effector 12, the clinician maydraw back the closure trigger 26 to its fully closed, locked positionproximate to the pistol grip 24. Then, the firing trigger 28 isactuated. The firing trigger 28 springedly returns when the clinicianremoves pressure. A release button 30 when depressed on the proximal endof the handle portion 20 releases any locked closure trigger 26.

A closure sleeve 32 encloses a frame 34, which in turn encloses a firingdrive member 36 that is positioned by the firing trigger 28. The frame34 connects the handle portion 20 to the end effector 12. With theclosure sleeve 32 withdrawn proximally by the closure trigger 26 asdepicted, the anvil 18 springedly opens, pivoting away from the elongatechannel 16 and translating proximally with the closure sleeve 32. Theelongate channel 16 receives a staple cartridge 37.

With particular reference to FIGS. 2-4, the firing bar 14 includes threevertically spaced pins that control the spacing of the end effector 12during firing. In particular, an upper pin 38 is staged to enter ananvil pocket 40 near the pivot between the anvil 18 and elongate channel16. When fired with the anvil 18 closed, the upper pin 38 advancesdistally within a longitudinal anvil slot 42 extending distally throughanvil 18. Any minor upward deflection in the anvil 18 is overcome by adownward force imparted by the upper pin 38. Firing bar 14 also includesa lowermost pin, or firing bar cap, 44 that upwardly engages a channelslot 45 in the elongate channel 16, thereby cooperating with the upperpin 38 to draw the anvil 18 and the elongate channel 16 slightly closertogether in the event of excess tissue clamped therebetween. The firingbar 14 advantageously includes a middle pin 46 that passes through afiring drive slot 47 formed in a lower surface of the cartridge 300 andan upward surface of the elongate channel 16, thereby driving thestaples therein as described below. The middle pin 46, by slidingagainst the elongate channel 16, advantageously resists any tendency forthe end effector 12 to be pinched shut at its distal end. To illustratean advantage of the middle pin 46, FIG. 5 depicts an alternative endeffector 12′ that lacks a middle pin on a firing bar 14′. In thisdepiction, the end effector 12′ is allowed to pinch shut at its distalend, which tends to impair desired staple formation.

Returning to FIGS. 2-4, a distally presented cutting edge 48 between theupper and middle pins 38, 46 on the firing bar 14 traverses through aproximally presented, vertical slot 49 in the cartridge 37 to severclamped tissue. The affirmative positioning of the firing bar 14 withregard to the elongate channel 16 and anvil 18 assure that an effectivecut is performed. The affirmative vertical spacing provided by theE-Beam firing bar 14 is suitable for the limited size available forendoscopic devices. Moreover, the E-Beam firing bar 14 enablesfabrication of an anvil 15 with a camber imparting a vertical deflectionat its distal end, similar to the position depicted in FIG. 5. Thiscambered anvil 15 advantageously assists in achieving the desired gap inthe end effector 12 even with an anvil 15 having a reduced thickness,which may be more suited to the size limitations of an endoscopicdevice.

With reference to FIGS. 6-9, the handle portion 20 is comprised of firstand second base sections 50 and 52, which are molded from a polymericmaterial such as a glass-filled polycarbonate. The first base section 50is provided with a plurality of cylindrically-shaped pins 54. The secondbase section 52 includes a plurality of extending members 56, eachhaving a hexagonal-shaped opening 58. The cylindrically-shaped pins 54are received within the hexagonal-shaped openings 58 and arefrictionally held therein for maintaining the first and second basesections 50 and 52 in assembly.

A rotating knob 60 has a bore 62 extending completely through it forengaging and rotating the implement portion 22 about its longitudinalaxis. The rotating knob 60 includes an inwardly protruding boss 64extending along at least a portion of the bore 62. The protruding boss64 is received within a longitudinal slot 66 formed at a proximalportion of the closure sleeve 32 such that rotation of the rotating knob60 effects rotation of the closure sleeve 32. It will be appreciatedthat the boss 64 further extends through frame 34 and into contact witha portion of the firing drive member 36 to effect their rotation aswell. Thus, the end effector 12 (not shown in FIGS. 6-9) rotates withthe rotating knob 60.

A proximal end 68 of the frame 34 passes proximally through the rotatingknob 60 and is provided with a circumferential notch 70 that is engagedby opposing channel securement members 72 extending respectively fromthe base sections 50 and 52. Only the channel securement member 72 ofthe second base section 52 is shown. The channel securement members 72,extending from the base sections 50, 52 serve to secure the frame 34 tothe handle portion 20 such that the frame 34 does not movelongitudinally relative to the handle portion 20.

The closure trigger 26 has a handle section 74, a gear segment section76, and an intermediate section 78. A bore 80 extends through theintermediate section 78. A cylindrical support member 82 extending fromthe second base section 52 passes through the bore 80 for pivotablymounting the closure trigger 26 on the handle portion 20. A secondcylindrical support member 83 extending from the second base section 52passes through a bore 81 of firing trigger 28 for pivotally mounting onthe handle portion 20. A hexagonal opening 84 is provided in thecylindrical support member 83 for receiving a securement pin (not shown)extending from the first base section 50.

A closure yoke 86 is housed within the handle portion 20 forreciprocating movement therein and serves to transfer motion from theclosure trigger 26 to the closure sleeve 32. Support members 88extending from the second base section 52 and securement member 72,which extends through a recess 89 in the yoke 86, support the yoke 86within the handle portion 20.

A proximal end 90 of the closure sleeve 32 is provided with a flange 92that is snap-fitted into a receiving recess 94 formed in a distal end 96of the yoke 86. A proximal end 98 of the yoke 86 has a gear rack 100that is engaged by the gear segment section 76 of the closure trigger26. When the closure trigger 26 is moved toward the pistol grip 24 ofthe handle portion 20, the yoke 86 and, hence, the closure sleeve 32move distally, compressing a spring 102 that biases the yoke 86proximally. Distal movement of the closure sleeve 32 effects pivotaltranslation movement of the anvil 18 distally and toward the elongatechannel 16 of the end effector 12 and proximal movement effects closing,as discussed below.

The closure trigger 26 is forward biased to an open position by a frontsurface 130 interacting with an engaging surface 128 of the firingtrigger 28. Clamp first hook 104 that pivots top to rear in the handleportion 20 about a pin 106 restrains movement of the firing trigger 28toward the pistol grip 24 until the closure trigger 26 is clamped to itsclosed position. Hook 104 restrains firing trigger 28 motion by engaginga lockout pin 107 in firing trigger 28. The hook 104 is also in contactwith the closure trigger 26. In particular, a forward projection 108 ofthe hook 104 engages a member 110 on the intermediate section 78 of theclosure trigger 26, the member 100 being outward of the bore 80 towardthe handle section 74. Hook 104 is biased toward contact with member 110of the closure trigger 26 and engagement with lockout pin 107 in firingtrigger 28 by a release spring 112. As the closure trigger 26 isdepressed, the hook 104 is moved top to rear, compressing the releasespring 112 that is captured between a rearward projection 114 on thehook 104 and a forward projection 116 on the release button 30. As theyoke 86 moves distally in response to proximal movement of the closuretrigger 26, an upper latch arm 118 of the release button 30 moves alongan upper surface 120 on the yoke 86 until dropping into an upwardlypresented recess 122 in a proximal, lower portion of the yoke 86. Therelease spring 112 urges the release button 30 outward, which pivots theupper latch arm 118 downwardly into engagement with the upwardlypresented recess 122, thereby locking the closure trigger 26 in a tissueclamping position, such as depicted in FIG. 8.

The latch arm 118 can be moved out of the recess 122 to release theanvil 18 by pushing the release button 30 inward. Specifically, theupper latch arm 118 pivots upward about pin 123 of the second basesection 52. The yoke 86 is then permitted to move proximally in responseto return movement of the closure trigger 26.

A firing trigger return spring 124 is located within the handle portion20 with one end attached to pin 106 of the second base section 52 andthe other end attached to a pin 126 on the firing trigger 28. The firingreturn spring 124 applies a return force to the pin 126 for biasing thefiring trigger 28 in a direction away from the pistol grip 24 of thehandle portion 20. The closure trigger 26 is also biased away frompistol grip 24 by engaging surface 128 of firing trigger 28 biasingfront surface 130 of closure trigger 26.

As the closure trigger 26 is moved toward the pistol grip 24, its frontsurface 130 engages with the engaging surface 128 on the firing trigger28 causing the firing trigger 28 to move to its “firing” position. Whenin its firing position, the firing trigger 28 is located at an angle ofapproximately 45° to the pistol grip 24. After staple firing, the spring124 causes the firing trigger 28 to return to its initial position.During the return movement of the firing trigger 28, its engagingsurface 128 pushes against the front surface 130 of the closure trigger26 causing the closure trigger 26 to return to its initial position. Astop member 132 extends from the second base section 52 to prevent theclosure trigger 26 from rotating beyond its initial position.

The surgical stapling and severing instrument 10 additionally includes areciprocating section 134, a multiplier 136 and a drive member 138. Thereciprocating section 134 comprises a wedge sled in the implementportion 22 (not shown in FIGS. 6-9) and a metal drive rod 140. The drivemember 138 includes first and second gear racks 141 and 142. A firstnotch 144 is provided on the drive member 138 intermediate the first andsecond gear racks 141, 142. During return movement of the firing trigger28, a tooth 146 on the firing trigger 28 engages with the first notch144 for returning the drive member 138 to its initial position afterstaple firing. A second notch 148 is located at a proximal end of themetal drive rod 140 for locking the metal drive rod 140 to the upperlatch arm 118 of the release button 30 in its unfired position. Themultiplier 136 comprises first and second integral pinion gears 150 and152. The first integral pinion gear 150 is engaged with a first gearrack 154 provided on the metal drive rod 140. The second integral piniongear 152 is engaged with the first gear rack 141 on the drive member138. The first integral pinion gear 150 has a first diameter and thesecond integral pinion gear 152 has a second diameter which is smallerthan the first diameter.

FIGS. 6, 8 and 9 depict respectively the handle portion 20 in the startposition (open and unfired), a clamped position (closed and unfired) anda fired position. The firing trigger 28 is provided with a gear segmentsection 156. The gear segment section 156 engages with the second gearrack 142 on the drive member 138 such that motion of the firing trigger28 causes the drive member 138 to move back and forth between a firstdrive position, shown in FIG. 8, and a second drive position, shown inFIG. 9. In order to prevent staple firing before tissue clamping hasoccurred, the upper latch arm 118 on the release button 39 is engagedwith the second notch 148 on the drive member 138 such that the metaldrive rod 140 is locked in its proximal-most position, as depicted inFIG. 6. When the upper latch arm 118 falls into the recess 122, theupper latch arm 118 disengages with the second notch 148 to permitdistal movement of the metal drive rod 140, as depicted in FIG. 9.

Because the first gear rack 141 on the drive member 138 and the gearrack 154 on the metal drive rod 140 are engaged with the multiplier 136,movement of the firing trigger 28 causes the metal drive rod 140 toreciprocate between a first reciprocating position, shown in FIG. 8, anda second reciprocating position, shown in FIG. 9. Since the diameter ofthe first pinion gear 150 is greater than the diameter of the secondpinion gear 152, the multiplier 136 moves the reciprocating section 134a greater distance than the drive member 138 is moved by the firingtrigger 28. The diameters of the first and second pinion gears 150 and152 may be changed to permit the length of the stroke of the firingtrigger 28 and the force required to move it to be varied. It will beappreciated that the handle portion 20 is illustrative and that otheractuation mechanisms may be employed. For instance, the closing andfiring motions may be generated by automated means.

One embodiment of an end effector 12 of the surgical stapling andsevering instrument 10 is depicted in further detail in FIGS. 18, 19,and 23-26. As described above, the handle portion 20 produces separateand distinct closing and firing motions that actuate the end effector12. The end effector 12 advantageously maintains the clinicalflexibility of this separate and distinct closing and firing (i.e.,stapling and severing). In addition, the end effector 12 introduces theaforementioned ability to affirmatively maintain the closed spacingduring firing after the clinician positions and clamps the tissue. Bothfeatures procedurally and structurally enhance the ability of thesurgical stapling and severing instrument 10 by ensuring adequatespacing for instances where an otherwise inadequate amount of tissue isclamped and to enhance the clamping in instances where an otherwiseexcessive amount of tissue has been clamped.

FIG. 10 depicts a staple cartridge embodiment 300 of the presentinvention installed in the end effector 12 with the firing bar 14 in itsunfired, proximal position. The staple cartridge 300 has a cartridgebody 302 that is divided by an elongated slot 310 that extends from aproximal end 304 of the cartridge 300 towards a tapered outer tip 306. Aplurality of staple-receiving channels 320 a-320 f are formed within thestaple cartridge body 302 and are arranged in six laterally spacedlongitudinal rows 500, 502, 504, 506, 508, 510, with three rows on eachside of the elongated slot 310. Positioned within the staple-receivingchannels 320 a-320 f are the staples 222. See FIGS. 10 and 11.

The cartridge 300 further includes four laterally spaced longitudinalrows of staple drivers 330 a, 330 b, 370 a, and 370 b as shown in FIG.11. The “first” inside staple drivers 330 a are slidably mounted withincorresponding channels 320 b and 320 c such that each driver 330 asupports two staples 222, one in a channel 320 b and one in a channel320 c. Likewise, the “second” inside drivers 330 b are slidably mountedwithin channels 320 d and 320 e such that each driver 330 b supports twostaples 222, one in a channel 320 d and one in a channel 320 e. The“outside” drivers 370 a and 370 b are slidably mounted within thestaple-receiving channels 320 a and 320 f, respectively. Each of theoutside drivers 370 a and 370 b supports a single staple 222. Drivers370 a are referred to herein as “first” outside drivers and drivers 370b are referred to herein as “second” outside drivers.

FIG. 12 illustrates a staple 222 that may be used in connection with thevarious embodiments of the present invention. The staple 222 includes amain portion 223 and two prongs 225. The prongs 225 each have a length“P” and the main portion has a width “W”. The reader will appreciatethat a variety of different types of staples may be employed. Forexample, for a vascular staple, “P” may be approximately 0.102 inches;for a regular staple, “P” may be approximately 0.134 inches; and for athick tissue staple, “P” may be approximately 0.160 inches. “W” may beapproximately 0.012 inches. Other sizes of staples 222 may be employedin the manners discussed below.

The inside staple drivers 330 a located on one side of the elongatedslot 310 are referred to herein as “first” inside staple drivers and theinside staple drivers 330 b located on the other side of the elongatedslot 310 are referred to herein as “second” inside staple drivers. Aswill be discussed in further detail below, in one embodiment, the secondinside staple drivers 330 b are identical to the first inside stapledrivers 330 a, except for their orientation in their respective channelsin the cartridge body 302.

FIGS. 13-15 illustrate one embodiment of a “first” inside double driver330 a for supporting and driving staples 222. As can be seen in thoseFigures, the staple driver 330 a has a primary driver portion 340 and asecondary driver portion 350 that is connected to the first primaryportion 340 by a central base member 360. The primary driver portion 340has a primary driver base 342 that has a groove 343 therein adapted tomate with a corresponding vertically extending tongue (not shown) in thecartridge body 302 for guiding and stabilizing the driver 330 a as itmoves within its respective channel. The primary driver portion 340further has a first forward support column 344 and a first rearwardsupport column 346 protruding upward from the first driver base 342. Thefirst forward support column 344 has a first forward staple-receivinggroove 345 therein and the first rearward support column 346 has a firstrearwardly staple-receiving groove 347 therein. See FIGS. 13-15. Thefirst forward support column 344 and the first rearward support column346 are spaced from each other and collectively form a first staplecradle 348 for supporting the main portion 223 of the staple 222 thereinin an upright position (i.e., prongs facing the anvil). Similarly, thesecondary driver portion 350 has a secondary driver base 352 and asecondary forward support column 354 and a secondary rearward supportcolumn 356 protruding out from the second driver base 352. The secondaryforward support column 354 has a secondary forward staple-receivinggroove 355 therein and the secondary rearward support column 356 has asecondary rearward staple-receiving groove 357 therein. The secondaryforward support column 354 and the secondary rearward support column 356are spaced from each other and collectively form a secondary staplecradle 358 for supporting the main portion 223 of another staple 222therein.

As can be seen in FIGS. 13 and 15, the central base member 360 has anangled rearwardly facing edge 362 adapted to be engaged by acorresponding sled cam as will be discussed in further detail below. Ascan be seen in FIGS. 13 and 14, in this embodiment, the secondaryforward support column 354 of the secondary driver portion is orientedrelative to the first rearward support column 346 such that the staple222 that is supported in the secondary staple cradle 358 islongitudinally offset from the staple 222 in the first staple cradle348. The reader will appreciate that the first inside drivers 330 a areeach installed in one orientation into a corresponding pair of channels320 b and 320 c located on one side of the elongated slot 310 in thecartridge body 302. The second inside staple drivers 330 b (located onthe opposite side of the elongated slot 310 from the first inside stapledrivers 330 a) comprise inside drivers 330 a rotated 180 degrees so thattheir respective angled surfaces 363 face towards the proximal end 304of the cartridge 300 to enable them to be installed in pairs ofcorresponding channels 320 d and 320 e. Thus, in this embodiment, onlyone inside driver configuration is employed which thereby eliminates theneed for two different inside staple driver configurations for channelson each side of the elongated slot 310.

FIGS. 16 and 17 illustrate one embodiment of a “first” outside stapledriver 370 a. As can be seen in those Figures, a first outside stapledriver 370 a has a second base 372 that has an angled rearwardly facingportion 374. Protruding upward from the second base 372 is a secondforward support column 375 that has a second forward staple-receivinggroove 376 therein. A second rearward support column 377 also protrudesupward from the second base 372 in a spaced-apart relationship withrespect to the second forward support column 375. The second rearwardsupport column 377 has a second rearward staple-receiving groove 378therein. The support columns 375, 377 collectively form a second staplecradle 379 that is configured to support a staple 222 therein in anupright position as illustrated in FIGS. 16 and 17. The staple drivers370 a also have a laterally protruding rib 371 which is received in acorresponding groove (not shown) in the cartridge body 302 for guidingand stabilizing the driver 370 a as it moves within its respectivechannel.

The reader will appreciate that a first outside driver 370 a isinstalled in one orientation into a corresponding channel 320 a on oneside of the elongated slot 310. A second outside staple driver 370 b (tobe located on the opposite side of the elongated slot 310 from the firstoutside staple drivers 370 a) comprises an outside driver 370 a rotated180 degrees so that the angled surface 374′ thereon faces toward theproximal end 304 of the cartridge 300 to enable it to be installed in acorresponding channel 320 f in the cartridge body 302. Thus, in thisembodiment, only one outside staple driver configuration is employedwhich avoids the need for two different outside staple driverconfigurations for channels on each side of the elongated slot 310.FIGS. 19 and 19A illustrate in cross-section one embodiment of a staplecartridge of the present invention mounted within one type of endeffector 12. The end effector 12 in this embodiment employs a “stepped”anvil 18 of the type illustrated in FIGS. 23-25. In other embodiments,however, the bottom surface of the anvil is planar and not stepped. Ascan be seen in FIGS. 19A, and 23-25, the anvil 18 has a central portion19 that is offset or not coplanar with the two lateral side portions 21,23. Accordingly, in this embodiment, the upper surface 306 of thecartridge 300 is provided with a recessed central portion 307 and twolateral side portions 309 that are adapted to closely mate with thecorresponding portions 19, 21, 23, respectively, of the anvil 18, whenthe anvil 18 is in the closed position. See FIG. 19A.

As can be seen in FIG. 24, in this embodiment, the under surfaces 200 ofanvil 18 are provided with a series of forming pockets 202 that may bearranged in rows that correspond to the rows of channels in thecartridge 300. That is, row 205 of pockets 202 may correspond to channelrow 500. Row 207 of pockets may correspond to channel row 502. Row 209of pockets 202 may correspond to channel row 504. Row 211 of pockets 202may correspond to channel row 506. Row 213 of pockets 202 may correspondto channel row 508. Row 215 of pockets 202 may correspond to channel row510. Each pocket 202 has at least one forming surface 203 therein thatis adapted to contact the ends of the staple prongs 225 being driventherein to thereby cause the prongs 225 to bend inwardly toward eachother. In one embodiment, each pocket 202 has two intersecting arcuateforming surfaces 203 that are oriented as shown in FIG. 14A. Eacharcuate forming surface has an apex 203′ that defines a maximum pocketdepth “Z”. However other forming pocket configurations could beemployed.

Returning to FIGS. 18 and 19, it can be seen that in one embodiment, thecartridge body 302 is mounted within the cartridge tray 224. Asillustrated in FIG. 19, the cartridge body 302 is formed with two insidelongitudinally extending slots 390 and two outside longitudinallyextending slots 392. Slots 390 and 392 extend from the proximal end 304of the cartridge to its tapered outer tip 306 (shown in FIG. 10). Thisembodiment further includes a wedge sled 400 that slidably supported onthe cartridge tray 224. One wedge sled embodiment 400 includes a pair ofinside sled cams 410, wherein one inside sled cam 410 corresponds to oneof the inside longitudinally extending slots 390 and wherein the otherinside sled cam 410 corresponds to the other inside longitudinallyextending slot 390. See FIG. 19. The wedge sled 400 further includes apair of outside sled cams 420, wherein one outside sled cam 420corresponds to one of the outside longitudinally extending slots 392 andthe other outside sled cam 420 corresponds to the other outsidelongitudinally extending slot 392 as shown in FIG. 19. When assembled,the cartridge tray 224 holds the wedge sled 400 and the drivers 330 a,330 b, 370 a, 370 b inside the cartridge body 302.

As can be seen in FIG. 18, the elongate channel 16 has a proximallyplaced attachment cavity 226 that receives a channel anchoring member228 on the distal end of the frame 34 for attaching the end effector 12to the handle portion 20. The elongate channel 16 also has an anvil camslot 230 that pivotally receives an anvil pivot 232 of the anvil 18. Theclosure sleeve 32 that encompasses the frame 34 includes a distallypresented tab 234 that engages an anvil feature 236 proximate but distalto the anvil pivot 232 on the anvil 18 to thereby effect opening andclosing of the anvil 18. The firing drive member 36 is shown as beingassembled from the firing bar 14 attached to a firing connector 238 bypins 240, which in turn is rotatingly and proximally attached to themetal drive rod 140. The firing bar 14 is guided at a distal end of theframe by a slotted guide 239 inserted therein.

FIGS. 20-23 illustrate one embodiment of the wedge sled 400 of thepresent invention. As can be seen in FIGS. 20 and 23, the wedge sled 400includes a central spacer portion 402 that extends between the insidesled cams 410. A pusher block 404 is formed on the central spacerportion 402 for engagement with the middle pin 46 of the firing bar 14.A side profile of one embodiment of an inside sled cam 410 is depictedin FIG. 21. As can be seen in that Figure, the inside sled cam 410 has abottom surface 412, and a first camming surface 414 that forms an angle“G” with the bottom surface 412 and a second camming surface 415 thatextends to a top surface 416. In one embodiment, for example, the angle“G” may be 35 degrees and the angle “G′” may be 20 degrees. The heightof the inside sled cam 410 (the distance between the bottom surface 412and the top surface 416) is represented as “first” sled cam height “H”.In one embodiment, distance “H’ is approximately 0.173 inches and thelength of the top surface 416 may vary from embodiment to embodiment. Aswill be further evident as the present Detailed Description proceeds,the first sled cam height represents the vertical distance that theinside sled cams 410 will drive the corresponding inside drivers 330 a,330 b toward the anvil 18 during operation.

The wedge sled 400 further comprises lateral spacer portions 406 thatextend between the inside sled cams 410 and the outside sled cams 420 asshown in FIGS. 20 and 23. A side profile of one embodiment of an outsidesled cam 420 is depicted in FIG. 22. In this embodiment, the outsidesled cam 420 has a bottom surface 422 and a first camming surface 424that forms an angle “I” with respect to the bottom surface 422 and asecond camming surface 425 that to a top surface 426. In one embodiment,angle “I” may be approximately 35 degrees and angle “I” may beapproximately 20 degrees. The height of the outside sled cam 420 (thedistance between the bottom surface 412 and the top surface 416) isrepresented as the “second” sled cam height “J”. In one embodiment,distance “J’ is approximately 0.163 inches. The second sled cam heightrepresents the vertical distance that the outside sled cams 420 willdrive the corresponding outside drivers 370 a, 370 b toward the anvil 18during operation. The reader will understand that the above-reciteddimensions are illustrative of one embodiment and may vary for otherembodiments.

With particular reference to FIG. 23, a portion of the staple cartridge300 is removed to expose portions of the elongate channel 16, such asrecesses 212, 214 and to expose some components of the staple cartridge300 in their unfired position. In particular, the cartridge body 302(shown in FIG. 18) has been removed. The wedge sled 400 is shown at itsproximal, unfired position with a pusher block 404 contacting the middlepin 46 (not shown in FIG. 23) of the firing bar 14. The wedge sled 400is in longitudinal sliding contact upon the cartridge tray 224 andincludes wedges sled cams 410, 420 that force upward the double drivers330 a, 330 b and the single drivers 370 b, 370 b as the wedge sled 400moves distally. Staples 222 (not shown in FIG. 23) resting upon thedrivers 330 a, 330 b, 370 a, 370 b are thus also forced upward intocontact with the anvil forming pockets 202 in anvil 18 to form closedstaples. Also depicted is the channel slot 45 in the elongate channel 16that is aligned with the elongated slot 310 in the staple cartridge 300.

FIG. 24 depicts the end effector 12, which is in an open position by aretracted closure sleeve 32, with a staple cartridge 300 installed inthe elongate channel 16. The firing bar 14 is at its proximal position,with the upper pin 38 aligned in a non-interfering fashion with theanvil pocket 40. The anvil pocket 40 is shown as communicating with thelongitudinal anvil slot 42 in the anvil 18. The distally presentedcutting edge 48 of the firing bar 14 is aligned with and proximally fromremoved from the vertical slot 49 in the staple cartridge 300, therebyallowing removal of a spent cartridge and insertion of an unfiredcartridge, which may be “snapfit” into the elongate channel 16.Specifically, in this embodiment, extension features 316, 318 of thestaple cartridge 300 engage recesses 212, 214, respectively (shown inFIG. 23) of the elongate channel 16.

FIG. 25 depicts the end effector 12 of FIG. 23 with all of the staplecartridge 300 removed to show the middle pin 46 of the firing bar 14 aswell as portion of the elongate channel 16 removed adjacent to thechannel slot 45 to expose the firing bar cap 44. In addition, portionsof the shaft 23 are removed to expose a proximal portion of the firingbar 14. Projecting downward from the anvil 18 near the pivot is a pairof opposing tissue stops 244 which serve to prevent tissue from beingpositioned too far up into the end effector 12 during clamping. FIG. 26depicts the end effector 12 in a closed position with the firing bar 14in an unfired position. The upper pin 38 is in the anvil pocket 40 andis vertically aligned with the anvil slot 42 for distal longitudinalmovement of the firing bar 14 during firing. The middle pin 46 ispositioned to push the wedge sled 400 distally so that the sled cams410, 420 contact and lift double drivers 330 a, 330 b and the singledrivers 370 a, 370 b, respectively, to drive them upwardly toward theanvil 18.

As can be appreciated from reference to FIGS. 14A, 15A and 19A, in oneembodiment of the present invention, the distance between the bottom ofthe first staple-receiving grooves 345, 347 forming the first staplecradle 349 and the apex 203′ of forming surfaces 203 of thecorresponding forming pocket 202 of anvil 18, when the anvil 18 is inthe closed position and when the inside driver 330 a, 330 b is supportedon the cartridge tray 224, is referred to herein as the first stapleforming distance “A”. The distance between the bottom of the secondarystaple-receiving grooves 345, 347 forming the secondary staple cradle349 and the apex 203′ of the forming surface 203 of the correspondingforming pocket 202 in the anvil 18 when the anvil 18 is in the closedposition and the inside driver 330 a, 330 b is supported on thecartridge tray 224 is referred to herein as the secondary staple formingdistance “B”. In one embodiment, the first staple forming distance “A”and the secondary staple forming distance “B” are substantially equal toeach other. In other embodiments, those distances “A” and “B” may differfrom each other.

As illustrated in FIGS. 16A and 19A the distance between the bottom ofthe second staple-receiving grooves 376, 378 that form the second staplecradle 379 and the apex 203′ of the forming surface 203 of acorresponding forming pocket 202 in anvil 18 when the anvil 18 is in theclosed position and the outside drivers 370 a, 370 b are supported onthe cartridge channel 224, is referred to herein as a “second” stapleforming distance “C”.

FIGS. 27 and 28 illustrate the forming of staples supported on some ofthe first outside drivers 370 a. In FIG. 27, one of the outside sledcams 420 of the wedge sled 400 is initially contacting one of theoutside drivers 370 a. As the wedge sled 400 continues in the drivingdirection represented by arrow “K” in FIG. 28, the outside sled cam 420causes the outside drivers 370 a drive the staples 222 supported therebyinto the staple forming pockets 202 in the anvil 18. Likewise, as thewedge sled 400 is driven in the driving direction “K”, the inside sledcams 410 contact the inside drivers 330 a, 330 b and causes them todrive the staples 222 supported thereby into the corresponding stapleforming pockets 202 in the anvil 18.

As indicated above, in some applications involving an area of variedtissue composition, it can be desirable to form rows of staples whereinthe formed (final) heights of the staples in a row that is the farthestdistance away from the cut line are greater than the formed (final)heights of those staples in the row that is closest to the cut line. Inother applications, it may be desirable for the formed heights of thestaples in a single row to increase (or decrease) from staple to staple.Another clinical benefit would be to have the formed heights of thestaples in the outermost rows larger than formed heights of the staplesin the inside rows. The various embodiments of the subject invention canprovide these results while employing identical staples in all of therows.

In the description to follow, those staples 222 in the outermost rows520, 530 of staples (those staples formed using the outside stapledrivers 370 a, 370 b) will be referred to hereinafter as staples 222′and those staples in the innermost rows 522, 524, 526, 528 of staples(those staples formed using the inside staple drivers 330 a, 330 b) willbe referred to hereinafter as staples 222″. It will be understood,however, that staples 222′ and 222″ are identical to each other prior tobeing formed by the various embodiments of the present invention. Thatis, staples 222′ and 222″ each have identical prong lengths “P” andwidths “W”.

Returning to FIGS. 14A-16A and 21 and 22, the above desired effects maybe attained by altering the staple forming distances “A”, “B”, and “C”relative to each other and/or the sled cam heights “H” and “J”. In oneembodiment of the subject invention, for example, the height “H” of eachof the inside sled cams 410 is substantially equal to the sled height“J” of each of the outside sled cams 420. See FIGS. 21 and 22. In thisembodiment, the staple forming distances “A” and “B” are substantiallyequal to each other, but distances “A” and “B” are less than the stapleforming distance “C”. The distance “D” between the bottoms of the firststaple-receiving grooves 345, 347 and the bottom surface 342′ of theprimary driver base 342 is substantially equal to the distance “E”between the bottoms of the secondary staple-receiving grooves 356, 357and the bottom surface 352′ of the secondary driver base portion 352.See FIG. 15. Also in this embodiment, the distance “F” between thebottoms of the second staple-receiving grooves 376 and 378 and thebottom surface 373 of the third base 372 of the outside drivers 370 a,370 b (FIG. 16) is less than distances “D” and “E” (FIG. 15). Becausethe forming distance “C” is greater than the forming distances “A” and“B”, the staples 222 supported and formed by the outside drivers 370 a,370 b are not compressed as much as the staples supported and formed bythe inside drivers 330 a, 330 b. It will be understood that similarresults may be attained on the opposite side of the elongated slot 310and the cut line 600 formed in the tissue by using the same arrangementsand sizes of inside drivers 330 b and outside drivers 370 b. In analternative embodiment, the same effect may be achieved by altering thedepths of the forming pockets 202 corresponding to the drivers 330 a and370 b such that forming distance “C” is greater than the formingdistances ““A” and “B”. That is, the depth (distance “Z′” in FIG. 16A)of the forming pockets 202 corresponding to the outside drivers 370 a.370 b may be greater than the depth (distance “Z” in FIG. 14A) of theforming pockets 202 that correspond to the inside drivers 330 a, 330 b.

FIG. 29 illustrates the rows of staples formed on each side of a cutline 600 utilizing this embodiment of the present invention wherein theforming distances “A” and “B” are equal to each other and the formingdistance “C” is greater than the forming distances “A” and “B”. Forexample, if forming distance “C” is 0.020″ greater than formingdistances “A” and “B”, the formed height of the outside staples 222′(represented as dimension “L” in FIG. 30) in rows 520 and 530 would be0.020 inches is greater than the formed height of the inside staples222″ (represented as dimension “M” in FIG. 31) in rows 522, 524, 526,528.

The same result may be achieved by utilizing another embodiment of thepresent invention wherein the forming distances “A”, “B” and “C” areessentially equal. In this embodiment, however, the height of each ofthe inside sled cams 410 (distance “H” in FIG. 21) is greater than theheight of each of the outside sled cams 420 (distance “J” in FIG. 22).Thus, because the height “H” of the inside sled cams 410 is greater thanthe height “J′” of the outside sled cams 420, the inside sled cams 410will drive the corresponding inside drivers 330 a, 330 b further towardsthe anvil than the outside sled cams 420 will drive the correspondingoutside drivers 370 a, 370 b. Such driving action will cause the staplessupported by the inside drivers 330 a, 330 b to be compressed to agreater extent than those staples supported by the outside drivers 370a, 370 b. For example, if distance “H” is 0.020 inches greater thandistance “J”, the formed height of staples 222′ in lines 520, 530 wouldbe 0.020″ greater than the formed height of staples 222″ in lines 522,524, 526, 528.

When employing yet another embodiment of the present invention, theoutside rows 520, 530 of staples 222′ and the inside rows 522, 528 ofstaples 222″ may be formed with heights that are greater than the formedheights of the staples 222″ in the inside rows 524, 526. See FIG. 32.This result is achieved by making the forming distances “C” greater thanthe forming distance “A” and making forming distance “A” greater thansecondary forming distance “B”.

Another embodiment of the present invention can be used to installstaples where it is desirable for the formed heights of staples in asingle row to vary. One such arrangement is depicted in FIG. 33. As canbe seen in FIG. 33, the formed heights of the staples 222′ in theoutside rows 520, 530 increase when moving from the proximal ends 521,531 of each row 520, 530, respectively to the distal ends 523, 533 ofeach row 520, 530, respectively. This effect may be accomplished bydecreasing the forming distance “C” for each succeeding driver 370 a,370 b. That is, the driver 370 a closest the proximal end of thecartridge 300 would be sized to establish a forming distance “C” that isgreater than the forming distance “C” achieved by the adjacent driver370 a and so on to achieve a condition wherein each succeeding staple222′ (moving in the direction from the proximal end to the distal end ofthe cartridge 300) would have larger formed heights. This result couldalso be attained in the staples 222″ in rows 522, 524, 526, 528 bysimilarly altering the forming distances “A” and/or “B” attained by eachdriver 330 a, 330 b. Likewise, formed heights of the staples 222′ in theoutside rows 520, 530 could be made to decrease when moving from theproximal ends 521, 531 of each row 520, 530, respectively, to the distalends 523, 533 of each row 520, 530, respectively. This result may beattained by increasing the forming distance of each succeeding driver370 a, 370 b. That is, the driver 370 a closest the proximal end of thecartridge 300 would have a forming distance “C” that is less than theforming distance “C” of the adjacent driver 370 a and so on to achieve acondition wherein each succeeding staple 222′ (moving in the directionfrom the proximal end to the distal end of the cartridge) would havesmaller formed heights. See FIG. 34.

In use, the surgical stapling and severing instrument 10 is used asdepicted in FIGS. 1-2 and 35-41. In FIGS. 1-2, the instrument 10 is inits start position, having had an unfired, fully loaded staple cartridge300 snap-fitted into the distal end of the elongate channel 16. Bothtriggers 26, 28 are forward and the end effector 12 is open, such aswould be typical after inserting the end effector 12 through a trocar orother opening into a body cavity. The instrument 10 is then manipulatedby the clinician such that tissue 248 to be stapled and severed ispositioned between the staple cartridge 300 and the anvil 18, asdepicted in FIG. 35. With reference to FIGS. 36 and 37, the clinicianthen moves the closure trigger 26 proximally until positioned directlyadjacent to the pistol grip 24, locking the handle portion 20 into theclosed and clamped position. The retracted firing bar 14 in the endeffector 12 does not impede the selective opening and closing of the endeffector 12, but rather resides within the anvil pocket 40. With theanvil 18 closed and clamped, the E-beam firing bar 14 is aligned forfiring through the end effector 12. In particular, the upper pin 38 isaligned with the anvil slot 42 and the elongate channel 16 isaffirmatively engaged about the channel slot 45 by the middle pin 46 andthe firing bar cap 44.

With reference to FIGS. 38 and 39, after tissue clamping has occurred,the clinician moves the firing trigger 28 proximally causing the firingbar 14 to move distally into the end effector 12. In particular, themiddle pin 46 enters the staple cartridge 300 through the firing driveslot 47 to affect the firing of the staples 222 (not shown in FIGS. 38and 39) via wedge sled 400 toward the anvil 18. The lowermost pin, orfiring bar cap 44, cooperates with the middle pin 46 to slidinglyposition cutting edge 48 of the firing bar 14 to sever tissue. The twopins 44, 46 also position the upper pin 38 of the firing bar 14 withinlongitudinal anvil slot 42 of the anvil 18, affirmatively maintainingthe spacing between the anvil 18 and the elongate channel 16 throughoutits distal firing movement.

With reference to FIGS. 40 and 41, the clinician continues moving thefiring trigger 28 until brought proximal to the closure trigger 26 andpistol grip 24. Thereby, all of the ends of the staples 222 are bentover as a result of their engagement with the anvil 18. The firing barcap 44 is arrested against a firing bar stop 250 projecting toward thedistal end of the channel slot 45. The cutting edge 48 has traversedcompletely through the tissue. The process is complete by releasing thefiring trigger 28 and by then depressing the release button 30 whilesimultaneously squeezing the closure trigger 26 to open the end effector12.

FIGS. 42-43 show the inside and outside sled cams 410, 420 of the sled400 having different heights so that the staples, when formed, may havedifferent formed heights. In particular, as shown in FIG. 42 the outsidesled cam 420 may be shorter than the inside sled cam 410. That way, theoutside staples may have a greater formed height than the insidestaples. FIG. 42 is a perspective view of the sled 400 with thedifferent heights for the inside and outside sled cams 410, 420. FIG. 43is a side view of the end effector 12 showing various stages of drivingthe staples 222 with a sled 400 having different heights for the insideand outside sled cams 410, 420. As can be seen in FIG. 43, the formedstaple 222 b may have a greater formed height than the formed staple 222a because the staple 222 b was driven by the outside cam sled 420 andthe staple 222 a was driven by the taller inside cam sled 410.

In another embodiment, as shown in FIG. 44, the heights of the driverportions 342, 352 of a double driver 330 may vary so that the staples,when formed, may have different heights. In particular, as shown in FIG.44, the secondary driver portion 352 may be shorter (having height “E”)than the primary driver portion 342 (having height “D”). That way, thestaple 222 a driven by the secondary driver portion 352 may have agreater formed height than the staple 222 b driven by the primary driverportion 342. In various embodiments, some or all of the inside doubledrivers 330 could have primary and secondary driver portions 342 ofdifferent heights. Further, the heights differential need not be all thesame. Different inside double drivers 330 could have different heightdifferentials.

In addition, the height of the primary and secondary driver portions342, 352 may be the same as or different from the height of the driverportions 372 of the outside staple drivers 370. That is, in variousembodiments, the driver height of the outside staple driver portion 372may be (1) different from the height of both driver portions 342, 352 ofthe inside double driver 330 when the driver portions 342, 352 are thesame height, (2) different from the height of both driver portions 342,352 when they are different heights, or (3) the same as the height forone of the driver portions 342, 352 when the driver portions 342, 352have different heights. Also, the heights of the driver portions 372 ofthe outside staple drivers 370 need not be all the same. Differentoutside staple drivers 370 could have different heights.

FIG. 45 shows an embodiment having different height drivers (e.g., theprimary driver portion 342 taller than the secondary driver portion 352)and with different depth anvil pockets 202. Varying the depth of theanvil pockets 202 can also affect the height of the formed staples. Allthings being equal, deeper pockets should result in longer formedstaples. In the illustrated embodiment, the pockets 202 corresponding tothe primary driver portion 342 are deeper than the pockets 202corresponding to the secondary driver portion 352. Some or all of thepockets 202 for each staple row 500-510 could be deeper. Also, the depthdifferentials need not be the same. A multitude of different depthscould be used in a single row 500-510 or across rows 500-510.

In addition, as shown in FIG. 46, staples 222 with differingpre-formation prong heights (“P”) may be used. In the illustratedembodiment, the longer staple 222 a is used with the shorter, secondarydriver portion 352 of an inside double driver 330 in comparison withstaple 222 b driven by the primary driver portion 342. The pre-formationstaple prong lengths may vary within a staple row 500-510 or acrossstaple rows. That is, for example, all of the staples in the inside rows504-506 could have the same pre-formation prong length x, all of thestaples in the intermediate rows 502, 508 could be longer (e.g., alength 1.10x), and all of the staples in the outer rows 500, 510 couldbe still longer (e.g., a length of 1.20x). As shown in FIG. 47, theanvil pockets 202 could have the same depth. In other embodiments,varying anvil pocket depths could be used.

FIG. 48 is a side view of the end effector 12 in an embodiment where theoutside staple drivers 370 have different heights. In particular, in theillustrated embodiment, the first staple driver 370′ is taller than thesecond staple driver 370″. In the illustrated embodiment, the staples222 have the same pre-formation prong length and the corresponding anvilpockets 202 have the same depth. As such, the formed staple 222″ formedwith the second outside staple driver 370″ is longer than the formedstaple 222′ formed with the first outside staple driver 370′.

FIG. 49 is a side view of the end effector 12 where the anvil 18 haspockets 202 of different depth for the staples 222 driven by a insidedouble driver 330. In the illustrated embodiment, the pockets 202corresponding to the primary driver portion 342 are deeper than thecorresponding pockets 202 for the secondary driver portion 352. In thisembodiment, the primary and secondary driver portions 342, 352 are thesame height and the staples 222 have the same pre-formation pronglength. The distance between the top of the primary driver portion 342and the top of the corresponding anvil pockets 202 is height “A” and thecorresponding height for the secondary portion 352 is height “B,” where“A” is greater than “B” by a height differential “h′”. This shouldresult in longer formed staples for the primary driver portion 342, asshown in FIG. 50.

FIGS. 51 and 60 show aspects of an end effector 12 according to otherembodiments that can be used to produce staples of different formedlengths. In the illustrated embodiment, the staple drivers 330, 370 aredriven in stages by a plurality of actuator wedge cams 709 at the distalend of a plurality of wedge band sets 710, 712, 714. In the illustratedembodiment, each wedge band set comprise four wedge bands (shown best inFIG. 56); two 720 for actuating the inner drivers 330 a,b and two 722for actuating the outer drivers 370 a,b. The wedge bands of the wedgeband sets 710, 712, 714 may be actuated in serial order and may ride ontop of one another in a stack to drive the staple drivers 330 a,b, 370a,b (and hence the staples 222) in serial stages. For example, the wedgebands of the lowermost actuator wedge band set 710 may be fired (oractuated) first, and may partially deploy the staples 222. The middlewedge band set 712, which rides on top of the lowermost wedge band set710 as shown in FIGS. 53-56, may be actuated next, which may have theeffect of beginning to form the staples 222. Then the uppermost wedgeband set 714, which rides on the middle wedge band set 712, may beactuated, which finishes the formation of the staples 222. FIG. 56illustrates this operation. In FIG. 56, the lowermost wedge band sets710 have been fired, the middle wedge band sets 712 have been partiallyfired, and the uppermost wedge band set 714 has not yet been fired.Thus, such an embodiment may comprise a plurality (in this case four) ofstacked wedge band sets, each stack comprising a wedge band from thelowermost set 710, the middle set 712, and the uppermost set 714.

The firing bar 716, with the e-beam firing mechanism 14, may then befired to cut the tissue clamped by the end effector 12. A hold downspring 718, which may be connected to the frame 34 at a crossbar 719,may engage and urge the firing bar 716 downward.

As can be seen best in FIGS. 54 and 56, the cumulative height of thewedge band stacks of inner row 720 or may be greater than the cumulativeheight of the wedge band stacks of the outer row 722 (by a heightdifferential h′). That way, the outer row of staples may have a greaterformed length than the inner row of formed staples, as shown in theexample of FIG. 55, where the outer row staple 222 a has a greaterformed length than the inner row staple 222 b. As shown the example ofFIG. 61, according to one embodiment, the wedge bands of the lowermostand middle wedge bands sets 710, 712 may be the same height, and theheight of the wedge bands for the outer row 722 of the uppermost wedgeband set 714 may be less than the height of the wedge bands of the innerrow 720 of the uppermost wedge band set 714 to provide the heightdifferential for the different wedge band stacks.

The end effector 12 in such an embodiment may still comprise a sled 400,but without the sled cams 410, 420, to keep the firing mechanism 14 outof the lockout in the channel (see FIGS. 3-4 and related text).

The inner and outer wedge band stacks 720, 722 may be tightly spacedwithin the frame 34. Accordingly, the end effector 12 may furthercomprise an actuator wedge band respective guide 702 for spreading outthe wedge band stacks 720, 722 when they enter the end effector 12 toalign with the staple drivers 330, 370. The wedge band guide 702 mayinclude wedge band channels for each of the inner and outer wedge bandstacks 720, 722. That is, in the illustrated embodiment, the wedge bandguide 702 may comprise four wedge band channels—two of the inner rows720 and two for the outer rows 722. FIGS. 58-60 show one side of thewedge band guide 702 in more detail. As shown in FIG. 60, the wedge bandchannels 730, 732 may force the wedge band stacks 720, 722 outward asthey enter the end effector 12. The inner wedge band channel 730 maydirect the inner wedge band stack 720 so that the inner wedge band stack720 aligns with the inner staple drivers 330 and the outer wedge bandchannel 732 may direct the outer row wedge band stack 722 so that theouter wedge band stack aligns with the outer staple drivers 370. In theillustrated embodiment, the channels 730, 732 are straight. In otherembodiments, one or both of the channels 730, 732 may comprise curvedportions.

FIG. 62 is a cross-sectional view of the shaft assembly 10 according tosuch an embodiment. As shown in FIG. 62, each wedge band set 710-714 mayhave its own actuation (or firing) bar. The lowermost actuation bar 740may actuate the wedge bands of the lowermost wedge band set 710, themiddle actuation bar 742 may actuate the wedge bands of the middle wedgeband set 712, and the uppermost actuation bar 744 may actuate the wedgebands of the uppermost wedge band set 714. The firing bar 716 foractuating the cutting instrument 14 may be connected to the uppermostwedge band set 714 so that the cutting instrument 14 is actuated withthe uppermost (last) wedge band set 714. In other embodiments, thefiring bar 716 may have its own actuation mechanism so that is may beactuated separately.

In practice, the clinician may choose (or select) to actuate less thanall of the wedge band sets 710-714 before actuating the firing rod 716to cut the tissue to thereby exercise some choice in the length of thestaples to be formed. For example, in various embodiments, the clinicianmay select to actuate the lowermost and middle wedge band sets 710,712—and not the uppermost wedge band set 714—before cutting.

FIGS. 63-69 illustrate an embodiment of an open linear stapling andcutting device 800 that may use multiple stacked wedge band sets toproduce staples of different formed lengths. In the illustratedembodiment, the anvil 810 is below the channel 809. As such, the staplesare driven down through tissue clamped in the end effector 12 as part ofthe stapling operation.

The device 800 may include an upper body piece 802 and a lower bodypiece 804. The upper body piece 802 may include a channel 806 in whichthe staple cartridge 809 is inserted. The anvil 810 may be connected tothe lower body piece 804 and face the staple cartridge 809 so that thestaples 222 can be formed against the staple forming surface 812 of theanvil 810. When the clinician is satisfied with the position of thetissue between the cartridge 809 and the anvil 810, the clinician maylock the device 800 using a clamp lever 814 of a clamp lever assembly816 connected to the upper body piece 802.

The staple drivers 820 in the cartridge 809 may be actuated in stagesusing multiple staged wedge band stacks. Because the staples 222 aredriven down in this embodiment, the wedge bands of the uppermost wedgeband set 822 may be actuated first to partially deploy the staples 222.Next, the wedge bands of the middle wedge band set 824, which ride onthe uppermost wedge band set 822, may be actuated to begin forming thestaples 222. Then the wedge bands of the lowermost wedge band set 826,which ride on the middle wedge band set 824, may be actuated, whichfinishes the formation of the staples 222.

In the illustrated embodiment, the firing bar 828, with the knife 830 atis distal end, is connected to the lowermost wedge band set 826 and isfired with the lowermost wedge band set 826. A hold down spring 832 mayengage and urge the firing bar 828 upward. A knife retainer 834 mayretain the firing bar 828 with the lowermost wedge band set 826.

As best shown in FIGS. 67-68, the clinician may actuate the wedge bandsets using a three-part actuation slide bar 840. The upper piece 842 mayactuate the uppermost (initial) wedge band set 822. The middle piece 844may actuate the middle wedge band set 824. The lower piece 846 mayactuate the lowermost (last) wedge band set 826.

To form staples of different formed heights, the staple pushers 820 mayhave different heights. For example, as shown in FIG. 66, one set ofstaple pusher 820 a could be shorter than another set of staple pushers820 b. As such, the formed staple 222 a, produced by the shorter staplepusher 820 a, may have a longer formed length than the formed staple 222b, formed by the longer staple pusher 820 b. In other embodiments, thestaples 222 may have different lengths or wire diameters to createdifferent length formed staples, and/or the pockets 202 in the anvil 810could have different depths to create different length formed staples.Also, the cumulative heights of the wedge band stacks could bedifferent.

According to various embodiments of the present invention, the stapledrivers could have a staple/driver interface that permits staples ofvarying wire diameter to be employed. For example, as shown in theembodiments of FIGS. 78-83, the outside staple drivers 370 a,b may havea raised dimple configuration on its upper surface for supportingstaples having differing wire diameters. The dimple configuration maycomprise, as shown in the illustrated embodiment, two inner sets ofoutwardly protruding dimples (or convex bumps) 620 a,b, and two outersets of dimples 622 a,b. Each set of dimples defines a receiving areawhere a staple 222 may sit in the upright position, as shown in FIGS.81-83. The dimples of the inner sets 620 a,b may be larger than thedimples of the outer dimple sets 622 a,b so that the receiving area ofthe inner sets 620 a,b is less than for the outer dimple sets 622 a,b.Nevertheless, due to the convex nature of the dimples, staples 222 ofvarying wire thicknesses may be accommodated, as shown in FIGS. 82 and83. For example, the dimples could be configured so that the stapledrivers 370 can accommodate staples having a wire diameter of 0.006inches to 0.012 inches, or some other range such as 0.004 inches to0.008 inches or 0.006 inches to 0.008 inches, etc. As such, staples ofdifferent wire thicknesses could be used in a single cartridge 306.Differing wire diameters would produce different formed staple heightsall other things being equal (e.g., same drive/crush distance, samepocket depth, etc.). In addition, as shown best in FIG. 78, the staplecradles for the inside drivers 330 may include sharp points 624 that mayinjure the tissue that is being stapled. The dimple configurations onthe outside staple drivers 370 lack such sharp points, which would tendto minimize the trauma on the tissue being stapled.

In the illustrated embodiment, the outer staple drivers 370 a,b have theraised dimple configuration in order to accommodate staples of differentwire diameters and the staple cradles of the inside staple drivers 342,352 can only support upright staples of one general wire diameter. Inother embodiments, the one or both of the inside staple drivers 342, 352may also or alternatively have the raised dimple configuration. Also,rather than using the raised dimple configuration, a v-shaped staplechannel 349, 379 may be used. Such a v-shaped channel may alsoaccommodate staples having different wire diameters. Also, staplepushers with staple interfaces that accommodate different staple wirediameters could be used with other types of staple drivers than theinside double and outside single staple drivers shown in FIGS. 78-83.

FIGS. 70-77 are cross-sectional frontal views of the end effector 12according to various embodiments of the present invention. In theembodiment shown in FIG. 70, the anvil 18 is stepped, having a centralportion 19 that is offset relative to (or not coplanar with) the twolateral side portions 21, 23. Also, the upper surface 306 of thecartridge 300 has a recessed central portion 307 and two lateral sideportions 309 (see FIG. 19A). All the staples 222 have the samepre-formation prong height and the corresponding anvil pockets 202 havethe same depth. However, due to the stepped nature of the anvil 18, thepockets 202 on the two lateral side portions 21, 23 of the anvil 18 areoffset from the pockets in the central portion 19 of the anvil.Offsetting the vertical position of the staple forming pockets 202 canaffect the length of the formed staples 222. All other things beingequal, staples formed by staple forming pockets that are elevated willhave a longer formed length than staples formed with pockets that arenot elevated. Also in this embodiment, the primary and secondary driverportions 342, 352 of the double inside drivers 330 a,b are the sameheight, and the height of the driver portion 372 of the outside stapledrivers 370 a,b is greater than the height of the driver portions 342,352 of the double inside staple drivers 330 a,b. Also, the inside andoutside sled cams 410, 4120 are the same height in this embodiment.

FIG. 71 shows an embodiment where the end effector 12 has a steppedcartridge tray 224 at the bottom of the cartridge 300 to match the stepsin the channel 16. In particular, in the illustrated embodiment, thecartridge tray 224 has a central portion 602 on which the double insidestaple drivers 330 a,b rest and outer lateral portions 604 on which theoutside staple drivers 370 a,b rest. As can be seen in FIG. 71, thecentral portion 602 of the cartridge tray 224 is elevated above thelateral portions 604. As such, the sled 400 may be configured so thatthe outside sled cam 420 is positioned lower than the inside sled cam410 so that the outside sled cam 420 can engage the lower outside driverportions 370 a,b.

The embodiment illustrated in FIG. 72 is similar to that shown in FIG.71 except that in FIG. 72 the cartridge 300 does not include thecartridge tray 224. Rather, the staple drivers 330, 370 rest directly onthe channel 16. Such an embodiment may be beneficial because it mayallow for more material (e.g., metal) in the channel 16 at points A andB than in a similar embodiment with the cartridge tray 224 (such asshown in FIG. 71).

The embodiment illustrated in FIG. 73 is also similar to that shown inFIG. 71 except that in FIG. 73 the cartridge tray 224 is raised slightlyrelative to the bottom on the channel 16 in comparison with theembodiment shown in FIG. 71. Such an embodiment may also allow for morematerial (e.g., metal) in the channel 16 at points A and B than in theembodiment shown in FIG. 71. According to other embodiments, the heightof the anvil 18 could be reduced to permit more material in the channel16 at points A and B.

The embodiment of FIG. 74 is similar to that used in FIG. 73 except thatno cartridge tray 224 is included in the embodiment of FIG. 74.

The embodiment of FIG. 75 is similar to that of FIG. 70 except than inFIG. 75 the outer rows of pockets 202 are formed in a compliant materialportion 610 of the anvil 18. The compliant material portion 610 may bemade from a material that is more compliant to the rest of the anvil 18.For example, the compliant material portion 610 may be made from plasticor a plastic composite material and the rest of the pockets may bedefined in a less-compliant material, such as stainless steel, of theanvil 18. The less-compliant anvil portion is sometimes referred toherein as “non-compliant” to distinguish it from the compliant materialsportion 610, although it should be recognized that the so-callednon-compliant material portion would be somewhat compliant, just lesscompliant than the compliant material portion 610. All things beingequal, staples formed with the outer pockets 202 formed in the compliantmaterial portion 610 of the anvil 18 would be longer than stapled formin the non-compliant (e.g., metal) portion of the anvil 18 because thecompliant material portion 610 would compress more during the stapleformation process.

FIGS. 76 and 77 collectively show another embodiment. In thisembodiment, the channel 16 includes a compliant material portion 612under the outside drivers 370. The complaint material portion 612 may beplastic or a composite plastic, for example. The inside drivers 330 mayrest on the less-compliant (or “non-compliant”) channel 16, which may bemade of metal (e.g., stainless steel). The outside sled cam 420 mayslightly compress the compliant material portions 612 under the outsidedrivers 370 when forming the staples in relation to the inside drivers330 on the channel 16, thereby forming slightly longer staples in theoutside rows. In other embodiments, the compliant material portions 612could be under the inside drivers 330 if it was desired to make theinside staples have a greater formed length.

According to other embodiments, staples of different materials could beused to produce staples of different formed lengths. The differentmaterials may have different modulus of elasticity so that they will beformed differently given the same driving force. Staples having a highermodulus of elasticity will tend to be deformed less given the samedriving force, thereby tending to produce staples having a longer formedlength. The different materials for the staples 222 may comprisetitanium, stainless steel, alloys, etc.

The present invention is also directed to other types of surgicalcutting devices that can create formed staples of different heights. Forexample, FIGS. 84-89 illustrate a circular stapler 900 that is capableof forming staples with different formed heights. As seen in FIG. 84,the circular stapler 900 includes a head 902, an anvil 904, anadjustment knob assembly 906, and a trigger 908. The head 902 is coupledto a handle assembly 910 by an arcuate shaft assembly 912. The trigger908 is pivotally supported by the handle assembly 910 and acts tooperate the stapler 900 when a safety mechanism (not shown) is released.When the trigger 908 is activated, a firing mechanism (not shown in FIG.84) operates within the shaft assembly 912 so that staples 914 areexpelled from the head 902 into forming contact with the anvil 904.Simultaneously, a knife 916 operably supported within the head 902 actsto cut tissue clamped between the head 902 and the anvil 904. Thestapler 900 is then pulled through the tissue leaving stapled tissue inits place.

FIGS. 85 and 86 illustrate one form of the anvil 904 and the head 902that may be employed in connection with various embodiments of thesubject invention. As can be seen in these figures, the anvil 904 mayhave a circular body portion 920 that has an anvil shaft 922 forattaching a trocar (not shown) thereto. The anvil body 920 has a stapleforming surface 924 thereon and may also have a shroud 926 attached tothe distal end thereof. The anvil 904 may be further provided with apair of trocar retaining clips or leaf-type springs 928 that serve toreleasably retain the trocar in retaining engagement with the anvilshaft 922. A plastic knife board 930 may be fitted into a cavity 932 inthe anvil body 904.

The head 902 may comprise a casing member 940 that supports a cartridgesupporting assembly in the form of a circular staple driver assembly 942therein that is adapted to interface with a circular staple cartridge944 and drive the staples 914 supported therein into forming contactwith the staple forming surface 924 of the anvil 904. The circular knifemember 916 is also centrally disposed within the staple driver assembly942. The proximal end of the casing member 940 may be coupled to anouter tubular shroud 946 of the arcuate shaft assembly 912 by a distalferrule member 948. More details regarding circular staples may be foundin U.S. patent application Ser. No. 11/541,151, entitled SURGICALCUTTING AND STAPLING DEVICE WITH CLOSURE APPARATUS FOR LIMITING MAXIMUMTISSUE COMPRESSION FORCE, filed Sep. 29, 2006, now U.S. Pat. No.7,665,647, which is incorporated herein by reference.

As can be seen in FIGS. 85-89, the staple driver assembly 942 maycomprise an outer ring of staple drivers 950 and an inner ring of stapledrivers 952. Correspondingly, the anvil 904 may comprise two concentricrings of staple forming pockets 202. Actuation of the firing trigger 908of the handle assembly 910 cause a compression shaft (not shown) of theshaft assembly 912 to move distally thereby driving the staple driverassembly 942 distally to fire the staples 914 into forming contact withthe staple forming surface 924 of the anvil 904. Thus, the outer stapledrivers 950, when actuated by the drive mechanism of the stapler 900,drive an outer ring of staples 914 into the clamped tissue and areformed by surface forming surface 924 of the anvil 904. Similarly, theinner staple drivers 952, when actuated by the drive mechanism of thestapler 900, drive an outer ring of staples 914 into the clamped tissueand are formed by surface forming surface 924 of the anvil 904.

The staple drivers 950, 952 could be of different heights to therebyform different length formed staples (all other things being equal). Forexample, as shown in the illustrated embodiment, the outer stapledrivers 950 may be shorter than the inner staple drivers 952 so that theouter formed staples are longer than the inner formed staples, as shownin FIG. 88. Of course, in other embodiments, the inner staple drivers952 could be shorter than the outer staple drivers 950. Further, theouter staple drivers 950 may not be a uniform height; there could beheight variation among the outer staple drivers 950. Similarly, therecould be height variation among the inner staple drivers 952.

In addition, staples with different pre-formation prong heights could beused. Also, the staple forming pockets 202 in the surface formingsurface 924 of the anvil 904 may have varying depths to thereby vary thelength of the formed staples. Also, as described above, some or all ofthe staple drivers 950, 952 may have a dimple configuration at theirinterface with the staples 914 to accommodate staples of different wirediameters or some other configuration that accommodates staples ofdifferent wire diameters (e.g., a v-shaped staple channel). Also, someof the pockets 202 in the anvil 1006 may be formed in a compliantmaterial portion of the anvil 1006. Also, the staples 914 could be madeof materials that have a different modulus of elasticity.

In other embodiments, as shown in FIGS. 90-95, the present invention isdirected to a linear stapler 1000 that is capable of forming staples ofdifferent heights. FIGS. 90-95 focus on the end effector 1002 for such alinear stapler 1000. The end effector 1002 may comprise a replaceablestaple cartridge 1004 and a linear anvil 1006. The cartridge 1004comprises staples which are driven into and formed by the anvil 1006when the device 1000 is actuated. Unlike the endocutters describedbefore, the anvil 1006 may be non-rotatable in the linear stapler 1000.To clamp tissue in the end effector 1002, the user may squeeze aclamping trigger (not shown), which causes the cartridge 1004 to slidedistally toward the anvil 1006 from an open position to a closedposition. More details regarding the operation and components of a linerstapler may be found in U.S. Pat. No. 5,697,543, entitled LINEAR STAPLERWITH IMPROVED FIRING STROKE, (“the '543 patent”), which is incorporatedherein by reference. Typically, such linear staplers do not comprise acutting instrument.

FIGS. 92-93 show the end effector 1002 with the outer cover of thecartridge 1004 removed. As can be seen in these figures, the staplecartridge 1004 may comprise a staple driver assembly 1010 comprising arow of inner staple drivers 1012 and a row of outer staple drivers 1014.The staple drivers 1012, 1014 could be of different heights to therebyform different length formed staples (all other things being equal). Forexample, as shown in the illustrated embodiment, the outer stapledrivers 1014 may be shorter than the inner staple drivers 1012 so thatthe outer formed staples 222 b are longer than the inner formed staples222 a, as shown in FIGS. 94-95. Of course, in other embodiments, theinner staple drivers 1012 could be shorter than the outer staple drivers1014. Further, the outer staple drivers 1014 may not be a uniformheight; there could be height variation among the outer staple drivers1014. Similarly, there could be height variation among the inner stapledrivers 1012. Also, the cartridge 1004 may comprise, for example, threerows of staples, where the outer two rows have shorter staple driversand the inner row has longer staple drivers.

In addition, staples 1008 having different pre-formation prong heightscould be used. Also, the staple forming pockets 202 in the surfaceforming surface 1016 of the anvil 1006 may have varying depths tothereby vary the length of the formed staples. Also, as described above,some or all of the staple drivers 1012, 1014 may have a dimpleconfiguration at their interface with the staples 1008 to accommodatestaples of different wire diameters or some other configuration thataccommodates staples of different wire diameters (e.g., a v-shapedstaple channel). Also, some of the pockets 202 in the anvil 1006 may beformed in a compliant material portion of the anvil 1006. Also, staples1008 of different materials could be used.

In operation, as described in more detail in the '543 patent, when theclamping trigger is retracted by the user, the anvil 1006 is cause toslide proximally toward the staple cartridge 1004 into the closedposition to clamp tissue in the end effector 102. The cartridge 1004 maycomprise a distally-extending tissue retaining pin 1020 that engages anopening 1022 in the anvil when the end effector 1002 is in the closedposition to retain the tissue between the cartridge 1004 and the anvil1002. When the clinician retracts the separate firing trigger (notshown), a distally extending firing bar (not shown) is actuated, whichactuates the staple drivers 1010 to drive the staples 1008.

In another embodiment, the linear stapler 1000 could be configured sothat the staple cartridge 1004 slides distally toward the anvil when theclamping trigger is actuated.

It should be recognized that stapling devices according to the presentinvention may combine some of the features described herein for creatingstaples of different formed lengths. For example, for embodiments havingdifferent staple crushing distances, the staples may all have the samepre-formation prong length or some staples may have differentpre-formation prong lengths. Also, the staples may all be made out ofthe same material, or staples made of different materials, withdifferent modulus of elasticity, could be used. Also, the staple wirediameters may all be the same or some of them could be different.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

Preferably, the various embodiments of the invention described hereinwill be processed before surgery. First, a new or used instrument isobtained and if necessary cleaned. The instrument can then besterilized. In one sterilization technique, the instrument is placed ina closed and sealed container, such as a plastic or TYVEK bag. Thecontainer and instrument are then placed in a field of radiation thatcan penetrate the container, such as gamma radiation, x-rays, orhigh-energy electrons. The radiation kills bacteria on the instrumentand in the container. The sterilized instrument can then be stored inthe sterile container. The sealed container keeps the instrument sterileuntil it is opened in the medical facility.

It is preferred that the device is sterilized. This can be done by anynumber of ways known to those skilled in the art including beta or gammaradiation, ethylene oxide, steam.

While the present invention has been illustrated by description ofseveral embodiments and while the illustrative embodiments have beendescribed in considerable detail, it is not the intention of theapplicant to restrict or in any way limit the scope of the appendedclaims to such detail. Additional advantages and modifications mayreadily appear to those skilled in the art. The various embodiments ofthe present invention represent vast improvements over prior staplemethods that require the use of different sizes of staples in a singlecartridge to achieve staples that have differing formed (final) heights.

Accordingly, the present invention has been discussed in terms ofendoscopic procedures and apparatus. However, use herein of terms suchas “endoscopic” should not be construed to limit the present inventionto a surgical stapling and severing instrument for use only inconjunction with an endoscopic tube (i.e., trocar). On the contrary, itis believed that the present invention may find use in any procedurewhere access is limited to a small incision, including but not limitedto laparoscopic procedures, as well as open procedures. Moreover, theunique and novel aspects of the various staple cartridge embodiments ofthe present invention may find utility when used in connection withother forms of stapling apparatuses without departing from the spiritand scope of the present invention.

What is claimed is:
 1. A staple cartridge configured to be containedwithin a channel of a stapling device that has a sled that isselectively actuatable in an axial direction and an anvil portion thatis selectively movable between open and closed positions to produce adifferent opening between the anvil portion and said staple cartridge inthe open and closed positions, said staple cartridge comprising: aplurality of staples; a cartridge body supportable within the staplingdevice for selective confronting relationship with the anvil portionthereof when in a closed position; a first staple driver movablysupported within said cartridge body for contact by the sled such that,as the sled is axially advanced through said cartridge body, said firststaple driver is configured to be driven in a direction toward the anvilportion when the anvil portion is in the closed position, and whereinsaid first staple driver defines more than one staple forming distancedefining at least one first formed staple height; and a second stapledriver movably supported within said cartridge body for contact by thesled such that, as the sled is advanced through said cartridge body,said second staple driver is configured to be driven in said directiontoward the anvil portion when the anvil portion is in the closedposition, wherein said second staple driver defines more than one stapleforming distance, and wherein at least one of said staple formingdistances of said second staple driver is different than any of saidstaple forming distances of said first staple driver and defines atleast one second formed staple height which is different than said atleast one first formed staple height.
 2. A stapling assembly,comprising: an elongate shaft; and an end effector extending from saidelongate shaft, wherein said end effector is responsive to a closingmotion transmitted through said elongate shaft to transition said endeffector toward a closed configuration, and wherein said end effectorcomprises: a sled; an anvil portion; a channel; and a staple cartridge,comprising: a plurality of staples; a cartridge body supported withinsaid channel for a confronting relationship with said anvil portion insaid closed configuration; a first staple driver movably supportedwithin said cartridge body for contact by said sled such that, as saidsled is axially advanced through said cartridge body, said first stapledriver is configured to be driven in a direction toward said anvilportion when said anvil portion is in said closed configuration, andwherein said first staple driver defines more than one staple formingdistance defining at least one first formed staple height; and a secondstaple driver movably supported within said cartridge body for contactby said sled such that, as said sled is advanced through said cartridgebody, said second staple driver is configured to be driven in saiddirection toward said anvil portion when said anvil portion is in saidclosed configuration, wherein said second staple driver defines morethan one staple forming distance, and wherein at least one of saidstaple forming distances of said second staple driver is different thansaid staple forming distances of said first staple driver and defines atleast one second formed staple height which is different than said atleast one first formed staple height.
 3. A stapling assembly,comprising: an elongate shaft; and an end effector extending from saidelongate shaft, wherein said end effector is responsive to a closingmotion transmitted through said elongate shaft to transition said endeffector toward a closed configuration, and wherein said end effectorcomprises: an anvil portion; and a staple cartridge, comprising: aplurality of staples; a cartridge body supportable within said endeffector for an opposing relationship with said anvil portion in saidclosed configuration; a first staple driver movably supported withinsaid cartridge body, wherein said first staple driver is configured tobe driven in a direction toward said anvil portion when said endeffector is in said closed configuration, and wherein said first stapledriver defines more than one staple forming distance defining at leastone first formed staple height; and a second staple driver movablysupported within said cartridge body, wherein said second staple driveris configured to be driven in said direction toward said anvil portionwhen said end effector is in said closed configuration, wherein saidsecond staple driver defines more than one staple forming distance, andwherein at least one of said staple forming distances of said secondstaple driver is different than said staple forming distances of saidfirst staple driver and defines at least one second formed staple heightwhich is different than said at least one first formed staple height.